Genmab is an international biotechnology company dedicated to improving the lives of patients through innovative antibody therapeutics. The Standards and Systems Intern will support data standards and clinical systems activities, gaining hands-on experience in clinical data management while contributing to process improvements and collaborating with cross-functional teams.
Responsibilities
- Contribute to meetings within the standards and systems group
- Assist in the intake, review, and documentation of Standards Change Requests
- Participate in internal alignment discussions and cross-functional meetings related to implementation of standards
- Participate in validation activities for the build of standard Case Report Forms (CRFs) and edit checks
- Assist in updating and maintaining the Genmab Standard CRF Template and Allowable Modification and Usage (AMU) Guide
- Assist with filing standards and system documentation within eTMF, ensuring accuracy and inspection readiness
- Help process ServiceNow requests for EDC user access and monitor compliance with access-control procedures
- Maintain and update the Standards & Systems SharePoint site, ensuring that content is current, organized, and accessible
- Attend standards and systems departmental meetings and/or study team meetings as required
- Contribute to drafting, updating, and improving departmental process documents, workflows, and best-practice guides
Skills
- Enrollment in a Bachelor or Master's program in Health Sciences, Data Science, or a related field
- Basic understanding of clinical trial regulatory environment
- Strong analytical and problem-solving abilities
- Excellent written and verbal communication skills
- Ability to work independently and as part of a collaborative team
- High attention to detail and commitment to quality work
- Genuine interest in clinical research and drug development
- Demonstrates initiative, a proactive attitude, and eagerness to learn in a fast-paced environment
- Effectively communicates and collaborates with team members, mentors, and stakeholders
- Applies academic expertise in open-source programming languages and adapts quickly to new tools and methodologies
- Maintains attention to detail and quality in all deliverables while managing multiple tasks
- Actively engages in the capstone project and leverages feedback to refine technical and professional skills
Company Overview
Genmab is a biotechnology company focused on developing fully human antibody therapeutics for the potential treatment of cancer. It was founded in 1999, and is headquartered in Copenhagen, Hovedstaden, DNK, with a workforce of 1001-5000 employees. Its website is https://www.genmab.com.
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